Safety in our System: High Alert Medications

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Safety in our SystemHigh Alert Medications

• Lynn Eschenbacher, Pharm.D.
• Medication Safety Officer
• Duke University Hospital

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Case Study

• Physician ordered Norcuron (Vercuronium) for a
  patient via Computerized Physician Order Entry
  (CPOE)
• Ordered via remote location- not at the bedside
• Accidentally prescribed for a patient on a
  medical unit, meant for a patient in the ICU

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Case Study

• Pharmacist processed and prepared the infusion,
  failing to recognize that a neuromuscular
  blocking agent should never be sent to a medical
  unit
• Auxiliary labels placed on bag
• High Alert medication
• Paralyzing agent
• Pharmacy technician delivered to medical unit and
  didnt question why not an ICU

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Case Study

• Independent double check performed by the nurses
  to verify
• Drug
• Pump settings
• Patient
• Infusion started and patient walked to the
  bathroom
• Patient fell to the floor once paralysis began to
  set in

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Case Study

• Patient called for help
• Rapid response team responded
• Nurse questioned if new drug hung could have done
  this
• Physician immediately stopped the infusion
• Patient treated and no long-term effects

ISMP Medication Safety Alert! May 31, 2007 Volume
12 Issue 11
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What Happened?

• Entered on wrong patient in CPOE
• No confirmation of correct patient or hardstop in
  CPOE for NMB outside of the ICU
• Unfamiliarity with the medication
• Didnt ask for clarification or information about
  the medication
• Auxiliary labels not read
• Multiple providers involved
• 6 Rights
• Patient, drug, dose, route, time, response
• Others?

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How Do Errors Occur?

• The Swiss Cheese Model

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Medication Safety Defined

• Adverse drug event (ADE)
• Any incident in which the use of a medication
  (drug or biologic) at any dose, may have resulted
  in an adverse outcome in a patient (JCAHO 2001)
• Adverse Drug Reaction (ADR)
• A response to a drug that is noxious and
  unintended, and that occurs at doses normally
  used in man for the prophylaxis, diagnosis or
  therapy of disease, or for the modification of
  physiological function (WHO 1972)
• Near Miss/Close Call
• Errors that have the capacity to cause injury,
  but fail to do so, either by chance or because
  they are intercepted (Leape 1995)

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High Alert Medications

• How does a medication get tagged high alert?
• A medication that is notorious for causing a lot
  of medication errors.
• A medication that requires an intern who has
  worked for less than 10 hours in a row to write
  for it.
• A medication that requires special care because
  if an error occurs it has the potential to result
  in significant patient harm.
• I have no idea.

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Answer

• A medication that is notorious for causing a lot
  of medication errors.
• A medication that requires an intern who has
  worked for less than 10 hours in a row to write
  for it.
• A medication that requires special care because
  if an error occurs it has the potential to result
  in significant patient harm.
• I have no idea.

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What Does the Evidence Tell Us?

• Warfarin and insulins caused
• One in every seven estimated adverse drug events
  treated in emergency departments
• More than a quarter of all estimated
  hospitalizations
• In the elderly, insulin, warfarin, and digoxin
  were implicated in
• One in every three estimated adverse drug events
  treated in emergency departments
• 41.5 of estimated hospitalizations
• Budnitz DS, Pollock DA, Weidenbach KN, et al.
  National surveillance of emergency department
  visits for outpatient adverse drug events. JAMA.
  20062961858-1866.

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IHI 5 Million Lives Campaign

• Reducing Harm from High-Alert Medications
• The Goal
• Reduce harm from high-alert medications by 50 by
  December 2008

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IHI 5 Million Lives Focus

• Anticoagulants
• Heparin and Warfarin
• Narcotics/Opiates
• Patient-Controlled Analgesia
• Insulin
• Sedatives
• e.g., Midazolam

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IHI Recommended Measures

• ADEs
• Related to Anticoagulant per 100 Admissions with
  Anticoagulant Administered
• Related to Insulin per 100 Admissions with
  Insulin Administered
• Related to Narcotic per 100 Admissions with
  Narcotic Administered
• Related to Sedative per 100 Admissions with
  Sedative Administered
• Percent of Patients Receiving
• Anticoagulant with Treatment Appropriately
  Managed According to Protocol
• Heparin with aPPT Outside Protocol Limits
• Insulin with Blood Glucose Level Outside Protocol
  Limits
• Insulin with Treatment Appropriately Managed
  According to Protocol
• Narcotic Who Receive Subsequent Treatment with
  Naloxone
• Narcotic with Treatment Appropriately Managed
  According to Protocol
• Sedative Who Receive Subsequent Treatment with
  Flumazenil
• Sedative with Treatment Appropriately Managed
  According to Protocol
• Warfarin with INR Outside Protocol Limits

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IHI Measure Examples

• The number of adverse drug events (ADEs)
  associated with an anticoagulant per 100
  admissions in which the patient was administered
  at least one dose of an anticoagulant, as
  detected using the IHI Global Trigger Tool (using
  only the Medication Module and Care Module
  triggers).
• The percentage of patients receiving insulin with
  blood glucose levels outside the safety limits
  set by the hospitals insulin protocol during
  insulin administration

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Duke University Hospital Approach

• Identify High Alert Medications
• Understand what causes harm at DUH
• Data analysis
• Decrease variation and standardize
• Develop long lasting solutions
• Involvement with front line staff up to senior
  leadership
• Demonstrate improvement with data

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Duke High Alert Medications

• Direct Thrombin Inhibitors
• Neuromuscular Blocking Agents
• IT administered medications
• Total Parenteral Nutrition (TPN)
• Antiarrhythmics (amiodarone IV, lidocaine IV,
  dofetilide)
• Vasopressors (dopamine, dobutamine, epinephrine,
  norepinephrine, phenylephrine)

• Potassium IV
• Heparin IV
• Opiates
• Chemotherapy IV and IT
• Benzodiazepines
• Warfarin
• Insulin IV

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Selection of High Alert Medications

• Based on
• Previous medication errors
• Sentinel Events
• ISMP, USP and other national data
• Increased risk of causing significant patient
  harm when they are involved in medication errors.
  
• Although mistakes may or may not be more common
  with these drugs, the consequences of an error
  are potentially more devastating to patients.

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Data Collection

• ISMP Quarterly Action Agenda
• IHI Trigger Tool
• Electronic Surveillance Tool
• Voluntary Reports
• Root Cause Analysis
• Failure Mode and Effect Analysis

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On-Line Reporting
Single Portal for all events Blood Transfusion
related, Falls, Patient Visitor issues,
Surgical/invasive, Treatment/testing, and
Equipment
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On-Line Reporting

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Areas of Focus

• Prescribing
• Preparation
• Dispensing
• Administration
• Monitoring

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Identification and Mitigation of Risk

• Analyze medication related events specific to
  institution
• Utilize scientific methodology to identify root
  causes and opportunities for improvement
• Multi-disciplinary teams to develop action items
  to address the root causes
• Culture and buy-in to adopt these improvements
• Mistake proof where possible to ensure long
  lasting solutions

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Identification and Mitigation of Risk

• Analyze
• RCA, FMEA
• Scientific Methodology
• Six Sigma, PDSA, FADE
• Culture
• AHRQ Culture of Safety Survey
• Mistake Proofing
• Elimination, Replacement, Facilitation,
  Detection, Mitigation

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Six Sigma

• Deployed January 2004
• 32 Black Belts
• 62 Green Belts
• DMAIC, DMADV, GE Workout, Lean, Change
  Management
• Six Sigma Oversight Committee with RAIL (rolling
  action item list)

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Multidisciplinary Participation

• Official Physician champions for each effort
• Report out at several physician, nursing and
  pharmacy forums
• Clinical Peer Review Committee
• Clinical Practice Council
• Performance Improvement Oversight Committee
• Medication Safety Council
• Knowledge experts included
• Address Issues that have been identified
• Share your institutions data

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Example Mistake Proofing
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Insulin Examples

• Standardization to one IV insulin nomogram
• CPOE Insulin order sets (Subcutaneous and IV) and
  can only order insulin from order set
• Standardization of hypoglycemia treatment
  protocol- placed in all patient charts
• Nutrition and insulin
• Example Insulin administered at MN and tube feed
  held at 3am due to residuals. What do you do?

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Insulin Advisor
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Opiate Examples

• Standardized the PCA concentrations available for
  the adult population
• CPOE
• Standardized ordering using a PCA orderset
• Added critical risk factor assessment
• Additional monitoring recommendations
• Lean body weight for dosing
• Hard stop for morphine PCA and ESRD
• RT consult for patients with sleep apnea
• Developed a pre-op screening electronic
  assessment tool with the critical risk factors
  related to potential oversedation highlighted in
  red at the top of the electronic form
• Developed pre-op screening education for patients
  to help set realistic expectations for post-op
  pain management

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PCA Advisor
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Pre-op screening alert
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Anticoagulation Examples

• Standardized ordering in CPOE (10/1/07)
• Direct Thrombin Inhibitors
• Heparin
• Warfarin
• Nursing protocol to alert physicians to returned
  lab results and prompts for change in orders
• Revised the pharmacist managed warfarin
  monitoring form

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Warfarin Monitoring Form
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Look-Alike High Alert Drugs
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Look-Alike Drugs
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Look-Alike Drugs
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Aoccdrnig to a rscheearch at Cmabrigde
Uinervtisy, it deosn't mttaer in waht oredr the
ltteers in a wrod are, the olny iprmoetnt tihng
is taht the frist and lsat ltteer be at the rghit
pclae. The rset can be a toatl mses and you can
sitll raed it wouthit porbelm. Tihs is bcuseae
the huamn mnid deos not raed ervey lteter by
istlef, but the wrod as a wlohe.
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Look-Alike/Sound-Alike Drugs

• hydralazine hydroxyzine
• cerebyx celebrex
• vinblastine vincristine
• chlorpropamide chlorpromazine
• glipizide glyburide
• daunorubicin doxorubicin

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Look-Alike/Sound-Alike Drugs TALL MAN LETTERING

• hydrALAZINE hydrOXYzine
• ceREBYX ceLEBRex
• vinBLASTine vinCRIStine
• chlorproPAMIDE chlorproMAZINE
• glipiZIDE glyBURIDE
• DAUNOrubicin DOXOrubicin

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DUH Look Alike/Sound Alike Efforts

• TallMan Lettering
• Smart Pumps, Automated Dispensing Cabinets,
  Medication Administration Record, bin in the
  central pharmacy, storeroom, IV room and
  satellites
• Future CPOE, Pharmacy computer system
• Posters highlighting similar products
• Example Ephedrine and Promethazine

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Communication and Education

• Key to Success
• Often an after thought, but needs to be part of
  the efforts
• Staff and Faulty
• Medication Safety Minutes
• Flyers
• Grand Rounds
• Patients
• Brochures
• Pamphlets
• Videos

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Medication Safety Flyer
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Medication Safety Flyer
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Demonstration of Improvement

• Current
• Balanced Scorecard (BSC)
• Reduction in ADEs resulting in harm
• Reduction in ADEs resulting in harm specific to
  opiates and insulin
• Increase in overall reporting
• Future
• Incorporation of ADE-Surveillance (Triggers) on
  BSC
• IHI Global Trigger tool

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Balanced Scorecard
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Critical Success Factors

• DUHS establishes priorities within each quadrant
  of the Balanced Scorecard.
• Clinical Quality, Customer, Finance, Work Culture
• Critical Success Factors (CSFs) help to
  communicate and measure these priorities.
• The CSFs cascade down throughout lower level
  scorecards within the organization and support
  the DUHS vision and strategy.

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Demonstration of Improvement

• Individual projects
• Process measures
• Outcome measures
• Unique to projects
• Oversight by Core Safety Team for Clinical
  Service Line or by Six Sigma Oversight Committee

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What We Know About Making Errors

• All of us make errors
• Errors are not made on purpose
• No one wants to admit errors if they know
  punishment is the result
• Error ? Bad Behavior
• Errors happen for a reason

Lucian Leape, MD
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Medication Safety

• Bottom Line If the system is not fixed ? the
  same error will happen again